Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform.

BACKGROUND: There is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy. METHODS: Pregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome. RESULTS: 1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08 - 0.3). CONCLUSION: Almost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines

Predictors of residual antimalarial drugs in the blood in community surveys in Tanzania.

Understanding pattern of antimalarials use at large scale helps ensuring appropriate use of treatments and preventing the spread of resistant parasites. We estimated the proportion of individuals in community surveys with residual antimalarials in their blood and identified the factors associated with the presence of the most commonly detected drugs, lumefantrine and/or desbutyl-lumefantrine (LF/DLF) or sulfadoxine-pyrimethamine (SP). A cross-sectional survey was conducted in 2015 in three regions of Tanzania with different levels of malaria endemicity. Interviews were conducted and blood samples collected through household surveys for further antimalarial measurements using liquid chromatography coupled to tandem mass spectrometry. In addition, diagnosis and treatment availability was investigated through outlet surveys. Multilevel mixed effects logistic regression models were used to estimate odds ratios for having LF/DLF or SP in the blood. Amongst 6391 participants, 12.4% (792/6391) had LF/DLF and 8.0% (510/6391) SP in the blood. Factors associated with higher odds of detecting LF/DLF in the blood included fever in the previous two weeks (OR = 2.6, p<0.001), living in districts of higher malaria prevalence (OR = 1.5, p<0.001) and living in a ward in which all visited drug stores had artemisinin-based combination therapies in stocks (OR = 2.7, p = 0.020). Participants in older age groups were less likely to have LF/DLF in the blood (OR = 0.9, p<0.001). Factors associated with higher odds of having SP in the blood included being pregnant (OR = 4.6, p<0.001), living in Mwanza (OR = 3.9, p<0.001 compared to Mbeya), fever in the previous two weeks (OR = 1.7, p<0.001) and belonging to older age groups (OR = 1.2, p<0.001). The most significant predictors identified were expected. History of fever in the past two weeks and young age were significant predictors of LF/DLF in the blood, which is encouraging. Antimalarial drug pressure was high and hence the use of recommended first-line drugs in combination with malaria Rapid Diagnostics Tests should be promoted to ensure appropriate treatment

Prevalence and antimicrobial sensitivity pattern of urinary tract infection among children with cerebral palsy, Moshi, Tanzania

Amon Ryakitimbo,1 Rune Philemon,1,2 Festo Mazuguni,3 Levina Msuya1,2 1Department of Pediatric and Child Health, Kilimanjaro Christian Medical University College, Moshi, Tanzania; 2Department of Pediatric and Child Health, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; 3Department of Epidemiology and Applied Biostatistics, Institute of Public Health, Kilimanjaro Christian Medical University College, Moshi, Tanzania Background: Urinary tract infection (UTI) in children with cerebral palsy (CP) is a challenging yet common clinical condition. Children with CP bare the greatest risk of contracting UTI because of their difficulties in neuromotor control which lead to delay of bladder control, causing incomplete bladder emptying and urine retention. Method: This was an analytical cross-sectional study that was conducted from September 2016 to March 2017 at Comprehensive Community Based Rehabilitation in Tanzania – Moshi and Kilimanjaro Christian Medical Centre Neurological Pediatrics Outpatient Clinic. All children who met the inclusion criteria were studied. Urine samples were collected at one point by catheterization, and urine dipstick and urine culture were done. Data were analyzed using SPSS version 20. Results: A total of 99 children were enrolled in the study. The median age was 4 years (3–8 years); 53.5% were aged between 2 and 4 years. More than half were male. UTI was detected in 13.1% (n=13) of the children. Five causative agents of UTI were isolated, namely Escherichia coli, Proteus mirabilis, Klebsiella pneumonia, Staphylococcus aureus, and Enterococcus faecalis. The two most common organisms, E. coli and P. mirabilis, both had low sensitivity to ampicillin and co-trimoxazole while they were sensitive to ciprofloxacin and ceftriaxone. Conclusion: UTI is a common finding among children with CP. E. coli and P. mirabilis are the commonest causative agents and are sensitive to ciprofloxacin and ceftriaxone but have low sensitivity to ampicillin and co-trimoxazole. Keywords: urinary tract infection, cerebral palsy, Moshi, Tanzani

Can training in advanced clinical skills in obstetrics, neonatal care and leadership, of non-physician clinicians in Malawi impact on clinical services improvements (the ETATMBA project) : a process evaluation

Objectives The ‘enhancing human resources and the use of appropriate technologies for maternal and perinatal survival in sub-Saharan Africa’ (ETATMBA) project is training emergency obstetric and new-born care (EmONC) non-physician clinicians (NPCs) as advanced clinical leaders. Our objectives were to evaluate the implementation and changes to practice. Design A mixed methods process evaluation with the predominate methodology being qualitative. Setting Rural and urban hospitals in 8 of the 14 districts of northern and central Malawi. Participants 54 EmONC NPCs with 3 years’ plus experience. Intervention Training designed and delivered by clinicians from the UK and Malawi; it is a 2-year plus package of training (classroom, mentorship and assignments). Results We conducted 79 trainee interviews over three time points during the training, as well as a convenience sample of 10 colleagues, 7 district officers and 2 UK obstetricians. Trainees worked in a context of substantial variation in the rates of maternal and neonatal deaths between districts. Training reached trainees working across the target regions. For 46 trainees (8 dropped out of the course), dose delivered in terms of attendance was high and all 46 spent time working alongside an obstetrician. In early interviews trainees recalled course content unprompted indicating training had been received. Colleagues and district officers reported cascading of knowledge and initial changes in practice indicating early implementation. By asking trainees to describe actual cases we found they had implemented new knowledge and skills. These included life-saving interventions for postpartum haemorrhage and eclampsia. Trainees identified the leadership training as enabling them to confidently change their own practice and initiate change in their health facility. Conclusions This process evaluation suggests that trainees have made positive changes in their practice. Clear impacts on maternal and perinatal mortality are yet to be elucidated